D-1604-2014 Class II Terminated
FDA drug recall D-1604-2014 was initiated by Hospira Inc. on Sep 9, 2014 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point. The recall status is terminated (terminated Mar 17, 2017). Affected quantity: 373,180 Carpuject units.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 1, 2014
- Initiation Date
- Sep 9, 2014
- Termination Date
- Mar 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 373,180 Carpuject units
Product Description
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32
Reason for Recall
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Distribution Pattern
Nationwide
Code Information
Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1604-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026